The United States Food and Drug Administration (FDA) has announced it will consider products outside the nanoscale, up to 1,000 nanometres (nm), to involve nanotechnology and so be potentially liable for “particular examination.”
In guidance issued yesterday, the FDA said materials in the usual nanoscale range (approximately 1nm to 100nm), as well as any larger products up to 1,000nm which are engineered to have properties caused by their dimensions, to fall under the nanotechnology category.
Nanomaterials can have different chemical properties and biological effects compared to larger-scale particles and are used in drugs to increase their bioavailability, decrease dosage or toxicity, or increase potency.
The Administration said the definition would only consider products to be “engineered” to have certain dimensions or exhibit certain properties if they had been subject to “deliberate and purposeful manipulation” by nanotechnology. It excluded materials that naturally occur in the nanoscale range, such as microorganisms and proteins.
It also said the incidental presence of particles in the nanoscale range in “conventionally-manufactured” products did not fall under the guidance if they had not been deliberately manipulated to be their size.
The definition will apply to new products and to changes to manufacturing processes which alter the dimensions, properties, or effects of an FDA-regulated product or any of its constituent parts. The guidance refers to finished drugs as well as ingredients used during manufacturing.
The FDA said while it did not have an opinion on whether nanotechnology is “inherently safe or harmful,” its use “may result in product attributes that differ from those of conventionally-manufactured products, and thus may merit particular examination.”
The Administration said its technical assessments of affected products “will be product-specific, taking into account the effects of nanomaterials in the particular biological and mechanical context of each product and its intended use.”
Although it is firming up its definitions, the FDA will continue to regulate nanotechnology products under existing statutes, saying it considers current frameworks for safety assessment flexible enough to apply to nanomaterials:
“Product-specific pre-market review, when required, offers an opportunity for FDA to better understand the properties and behaviour of products that involve the application of nanotechnology. Where products that involve the application of nanotechnology are not subject to premarket review, we urge industry to consult with the Agency early in the product development process.”